Control module interface for MRI biopsy device

ABSTRACT

A biopsy system includes a first external device, a second external device and a control module interface. The control module interface is in electrical communication with both the first and second external devices, and the control module interface is in mechanical communication with the second external device. The control module interface is configured to be positioned remotely from at least one of the first and second external devices. The control module interface comprises a motor, operational electronics, a shaft connector assembly, an electrical connector and a cabinet configured to house the motor and operational electronics. The motor is in mechanical communication with the second external device via a mechanical cable. The operational electronics are configured to permit control of the motor and a motorized component of the second external device. In some embodiments, the mechanical cable comprises a flexible shaft cable, such as a speedometer cable.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI (magneticresonance imaging) guidance, PEM (positron emission mammography)guidance, BSGI (breast-specific gamma imaging) guidance, MBI (molecularbreast imaging) guidance, or otherwise. Merely exemplary biopsy devicesare disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatusfor Automated Biopsy and Collection of Soft Tissue,” issued Jun. 18,1996; U.S. Pat. No. 6,086,544, entitled “Control Apparatus for anAutomated Surgical Biopsy Device,” issued Jul. 11, 2000; U.S. Pub. No.2003/0109803, entitled “MRI Compatible Surgical Biopsy Device,”published Jun. 12, 2003; U.S. Pub. No. 2007/0118048, entitled “RemoteThumbwheel for a Surgical Biopsy Device,” published May 24, 2007; U.S.Pub. No. 2008/0214955, entitled “Presentation of Biopsy Sample by BiopsyDevice,” published Sep. 4, 2008; U.S. Provisional Patent ApplicationSer. No. 60/869,736, entitled “Biopsy System,” filed Dec. 13, 2006; andU.S. Provisional Patent Application Ser. No. 60/874,792, entitled“Biopsy Sample Storage,” filed Dec. 13, 2006. The disclosure of each ofthe above-cited U.S. Patents, U.S. Patent Application Publications, andU.S. Provisional Patent Applications is incorporated by referenceherein. While several systems and methods have been made and used forobtaining a biopsy sample, it is believed that no one prior to theinventors has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a schematic view of an exemplary biopsy system;

FIG. 2 depicts an exemplary biopsy device that may be used with thebiopsy system of FIG. 1;

FIG. 3 depicts a side cross-sectional view of the biopsy device of FIG.2, with a probe portion separated from a holster portion;

FIG. 4 depicts a perspective view of an exemplary control moduleinterface mounted on a magnetic resonance imaging cart;

FIG. 5 depicts a perspective view of the control module of FIG. 1;

FIG. 6 depicts a perspective view of the control module of FIG. 1 withthe top plate of the casing removed;

FIG. 7 depicts perspective view of an exemplary casing and exemplarypiezo motor mounting of the control module interface of FIG. 5 with theother components removed;

FIG. 8 depicts a perspective view of an exemplary cutter motor assemblyof the control module of FIG. 1; and

FIG. 9 depicts a detailed partial perspective view of the cutter motorassembly of FIG. 8;

FIG. 10 depicts a lateral cross-sectional view of the cutter motorassembly of FIG. 8, taken along a longitudinal plane; and

FIG. 11 depicts a transverse cross-sectional view of an exemplarymechanical cable that may be used with the biopsy system of FIG. 1.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

FIG. 1 depicts a schematic view of an exemplary biopsy system (2), whichincludes a control module interface (100), a biopsy device holster(200), an external input device (900), and a vacuum control module(400). As will be described in greater detail below, control moduleinterface (100) may be configured to communicate with one or moreexternal devices. In the illustrated version, control module interface(100) is in communication with biopsy device holster (200), input device(900), and vacuum control module (400). In this example, biopsy deviceholster (200) is a component of a biopsy device (250) that is configuredto obtain a biopsy sample; and vacuum control module (400) is configuredto work in conjunction with biopsy device (250) to obtain the sample.Control module interface (100) may be configured to be combined with abiopsy device holster (200) that is designed for use under stereotacticguidance, ultrasound guidance, MRI guidance, PEM guidance, BSGIguidance, MBI guidance, or another type of guidance; or any othersuitable type of holster (200).

One or more of the components of biopsy system (2) may be configured tobe mounted to, fastened to, or otherwise coupled with a cart (50) toincrease portability. As shown in FIG. 4, control module interface (100)and vacuum control module (400) are mounted to cart (50) in this example(e.g., using clips, clamps, bolts, screws, complementary structuralfeatures for engagement, etc.). Portability of vacuum control module(400) and control module interface (100) may be desirable in magneticresonance imaging (MRI) suite settings or in other settings. The use ofelectric motors, which may be incorporated within control moduleinterface (100), may be restricted in magnetic environments, such as MRIsuites. Therefore, mounting control module interface (100) and vacuumcontrol module (400) may allow a user to easily position thesecomponents at an adequate distance (e.g., at least twelve feet) awayfrom any magnetic equipment. Of course, a plurality of carts (50) may beused, as may portions of carts (50). Carts (50) may also be adjustablein any suitable fashion. Alternatively, control module interface (100)and/or vacuum control module (400) may be provided at any other suitablelocation(s) during use. Cart (50), vacuum control module (400), and/orcontrol module interface (100) may also present one or more features toprovide storage of excess cables, fluid communication tubes, etc.

I. Exemplary Biopsy Device

FIGS. 2-3 illustrate one merely exemplary biopsy device (250) that maybe incorporated into biopsy system (2). As shown, biopsy device (250)comprises a probe (300) and a holster (200). Probe (300) and holster(200) are separable in this example, though such separability is notnecessary. In some settings, biopsy device (250) may be manipulated andoperated by a single hand of a user (e.g., using ultrasound guidance,etc.). However, it will be appreciated in view of the disclosure hereinthat biopsy device (250) may be configured to be mounted to a table,fixture, or other device, such as for use in a stereotactic or X-raysetting, an MRI setting, PEM setting, BSGI setting, MBI setting, or anyother setting. By way of example only, holster (200) may be coupled witha targeting set, such as the targeting set disclosed in U.S.Non-Provisional patent application Ser. No. 12/337,872, entitled“MUTLI-ORIENTATION TARGETING SET FOR MRI BIOPSY DEVICE,” filed on evendate herewith, the disclosure of which is incorporated by referenceherein. Holster (200) may also be coupled with a targeting grid and cubeas disclosed in U.S. Pub. No. 2007/0255170, entitled “BIOPSY CANNULAADJUSTABLE DEPTH STOP,” published Nov. 1, 2007, the disclosure of whichis incorporated by reference herein.

In some versions, biopsy device (250) is configured and usable inaccordance with the teachings of U.S. Non-Provisional patent applicationSer. No. 12/337,874, entitled “MECHANICAL TISSUE SAMPLE HOLDER INDEXINGDEVICE,” filed on even date herewith, the disclosure of which isincorporated by reference herein. In some other versions, biopsy device(250) is configured and usable in accordance with the teachings of U.S.Non-Provisional patent application Ser. No. 12/337,674, entitled “BIOPSYDEVICE WITH SLIDING CUTTER COVER,” filed on even date herewith, thedisclosure of which is incorporated by reference herein. In otherversions, biopsy device (250) is configured and usable in accordancewith the teachings of U.S. Non-Provisional patent application Ser. No.12/337,911, entitled “BIOPSY DEVICE WITH DISCRETE TISSUE CHAMBERS,”filed on even date herewith, the disclosure of which is incorporated byreference herein. In still other versions, biopsy device (250) isconfigured and usable in accordance with the teachings of U.S.Non-Provisional patent application Ser. No. 12/337,997, entitled “TISSUEBIOPSY DEVICE WITH CENTRAL THUMBWHEEL,” filed on even date herewith, thedisclosure of which is incorporated by reference herein. Alternatively,biopsy device (250) may have a variety of other configurations andoperational methods.

Biopsy device (250) may also be formed of materials that are safe insuch environments. For instance, biopsy device (250) may be formed ofmaterials permitting biopsy device (250) to be safely used in an MRIimaging environment, such that biopsy device (250) is “MR safe” or MRcompatible, and such that MRI interference is minimized if notprevented. Of course, it will be appreciated in view of the disclosureherein that biopsy device (250) may be used in a variety of othersettings and combinations.

A. Exemplary Probe

As shown in FIGS. 2-3, probe (300) of the present example comprises aneedle portion (10), a body portion (112), and a tissue sample holder(140). Needle portion (10) has a blunt tip (14) and a transverse tissuereceiving aperture (16) located proximally from the blunt tip (14). Forinstance, needle portion (10) may be introduced into a patient's breastthrough a separate cannula (not shown) that has a tissue piercing tipand a aperture configured to align with tissue receiving aperture (16)of needle portion (10). In alternate embodiments, blunt tip (14) may bereplaced with a tissue piercing tip (not shown). Tissue piercing tip maybe configured to penetrate tissue without requiring a high amount offorce, and without requiring an opening to be preformed in the tissueprior to insertion of the needle portion (10). One suitableconfiguration for a tissue piercing tip is disclosed in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Tip (14) may also be RF capable orultrasonic capable, to facilitate insertion of tip (14) in tissue, tofacilitate hemostasis, etc. Other suitable configurations for a blunttip (14) or tissue piercing tip will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Thumbwheels (60, 65) are secured relative to needle portion (10), andare operable to rotate needle portion (10). In particular, thumbwheels(60, 65) are operable to reorient the position of aperture (16) relativeto the central axis defined by needle portion (10), such as to obtainvarious biopsy samples at different angular positions in a patient'sbreast without having to withdraw needle portion (10) from the patient'sbreast. An illustrative example of such rotation and acquisition ofmultiple tissue samples is disclosed in U.S. Pat. No. 5,526,822, thedisclosure of which is incorporated by reference herein. Of course, someversions may provide rotatability of needle portion (10) in some otherway, or not provide any rotatability of needle portion (10) at all. Forinstance, a thumbwheel (60, 65) may alternatively be located on eitheror both sides of biopsy device (250), at the rear of biopsy device(150), remote from biopsy device (250), and/or in any other suitablelocation(s). By way of example only, a thumbwheel (60, 65) may beconfigured, located, and/or operated in accordance with any of theteachings of U.S. Non-Provisional patent application Ser. No.12/337,997, entitled “TISSUE BIOPSY DEVICE WITH CENTRAL THUMBWHEEL,”filed on even date herewith, the disclosure of which is incorporated byreference herein.

A hollow tubular cutter (54) is disposed within needle portion (10), andis operable to sever tissue protruding through tissue receiving aperture(16) when needle portion (10) is inserted in a patient. Furthermore,cutter (54) defines a cutter lumen (56), through which severed tissuesamples may be communicated proximally to reach tissue sample holder(140). Tissue samples may be communicated proximally through cutterlumen (56) under the influence of a vacuum and/or pressurized air orusing any other suitable techniques. At least a portion of tissue sampleholder (140) is removable from probe body portion (112) in this example,to permit retrieval of tissue samples therefrom.

As shown in FIG. 3, an overmold (285) is provided about cutter (54).Overmold (285) has an externally threaded portion and an external hexportion, and is secured unitarily to cutter (54). A gear (85) isprovided about the hex portion of overmold (285), and is operable torotate unitarily with overmold (285) while also being able to translatelongitudinally relative to overmold (285). For instance, gear (85) mayhave an internal hex profile that complements an external hex profile ofovermold (285). Alternatively, a key-keyway relationship or other typeof structural relationship may be provided. A nut (286) is securedrelative to body portion (112), and has an internal threaded regionthrough which externally threaded portion of overmold (285) passes. Inparticular, as overmold (285) rotates, engagement between threading ofovermold (285) and threading of nut (286) results in translationalmovement of overmold (285) relative to nut (286) (and, hence, relativeto body portion (112)). It should therefore be understood that rotationof gear (85) can cause simultaneous rotation and longitudinaltranslation of overmold (285) relative to body portion (112); and hence,simultaneous rotation and longitudinal translation of cutter (54)relative to body portion (112). A portion of gear (85) is exposedthrough body portion (112) of probe (300). Gear (85) may thus itself berotated by gear (238), as will be explained in greater detail below,when probe (300) is coupled with holster (200).

A pair of tubes (502, 504) are coupled with probe (300), and areoperable to provide fluid communication (e.g., vacuum, saline,pressurized air, venting, etc.) between probe (300) and vacuum controlmodule (400) and/or any other device or system. For instance, tube (502)may provide fluid communication with a portion of the interior of needleportion (10) that is exterior to cutter (54). Tube (504) may providefluid communication with cutter lumen (56) via tissue sample holder(140). Suitable structures and techniques for providing such fluidcommunication, as well as other suitable features of or for probe (300),are disclosed in U.S. Non-Provisional patent application Ser. No.12/337,997, entitled “TISSUE BIOPSY DEVICE WITH CENTRAL THUMBWHEEL,”filed on even date herewith, the disclosure of which is incorporated byreference herein. Other suitable structures and techniques for providingsuch fluid communication as well as other suitable features of or forprobe (300), are disclosed in U.S. Pub. No. 2008/0195066, entitled“Revolving Tissue Sample Holder For Biopsy Device,” published Aug. 14,2008, the disclosure of which is incorporated by reference herein.Alternatively, fluid communication may be provided in any other suitablefashion, to the extent that any fluid communication is provided at all;and probe (300) may have any other suitable structures, features,components, and configurations, as desired.

B. Exemplary Holster

As shown in FIG. 1, holster (200) is in communication with controlmodule interface (100), input device (900) (via control module interface(100)) and vacuum control module (400) (via control module interface(100)). As shown in FIGS. 2-3, holster (200) of the present examplecomprises a body portion (212) and a mechanical cable assembly (215)extending therefrom. A strain relief boot (209) is provided at theinterface of body portion (212) and mechanical cable assembly (215). Asshown in FIG. 11, mechanical cable assembly (215) comprises a flexiblecable (217) and a sheath (219). Flexible cable (217) may be similar to aspeedometer cable, such that rotation of cable (217) is communicatedalong the length of cable (217) without significantly twisting up orbinding cable (217). Cable assembly (215), including any or all of itscomponents, may be formed of MR compatible materials, such that cableassembly (215) is MR safe. As will be described in greater detail below,cable (217) is configured to receive rotational motion from shaftconnector (164) of control module interface (100), and transmit suchrotational motion to gear (225) of holster (200).

Cable (217) of the present example is of sufficient length to permitbiopsy device (250) to be operated at least approximately 10 to 12 feetaway from control module interface (100) and vacuum control module(400). For instance, such a distance may allow biopsy device (250) to besuccessfully operated within the magnetic field of an MRI suite, whilereducing exposure or preventing exposure of control module interface(100) and vacuum control module (400) to such a magnetic field.

Holster (200) includes a cutter driving mechanism (230), which isconfigured to ultimately transfer rotational motion of cable (217) intosimultaneous rotation and translation of cutter (54). Cutter drivingmechanism (230) comprises several gears (225, 227, 231, 238) and a shaft(229). As noted above, gear (225) is coupled with cable (217), and isconfigured to receive rotational motion from cable (217). Gear (225) maybe engaged with and transfer rotational motion to another gear (227),which may transfer the rotational motion to yet another gear (231) viashaft (229). Gear (231) may in turn transfer the rotational motion toanother gear (238). A portion of gear (238) may be exposed through bodyportion (212) of holster (200), permitting gear (238) to mesh with gear(85) when probe (300) is coupled with holster (200). As noted above,gear (238) may thus transfer rotational motion to gear (85). It shouldtherefore be understood in view of the teachings herein that rotation ofcable (217) by shaft connector (164) may ultimately be converted intosimultaneous rotation and translation of cutter (54), by virtue of theconfigurations and relationships between cable (217), gears (225, 227,231, 238, 85), shaft (229), overmold (285), nut (286), body portion(112), and cutter (54). Of course, a variety of other structures,configurations, components, devices, and techniques may be used toprovide rotational and/or translational movement of cutter (54).

Holster (200) of the present example further comprises a piezo motor(210) and an encoder (220). Piezo motor (210) may comprise a USR30-B4motor by Shinsei Corporation of Tokyo, Japan, or any other suitablemotor. Alternatively, a non-piezo motor may be used, if desired. Encoder(220) may comprise a R22i encoder by Renco Encoders, Inc. of Goleta,Calif., or any other suitable encoder. Encoder (220) may beoperationally coupled with one or more of piezo motor (210), cutterdriver mechanism (230), or any other component of holster (200). Piezomotor (210) may be operable to rotate a portion of tissue sample holder(140) (e.g., to successively index discrete tissue sample chambers tocutter lumen (56) for collection of discrete tissue samples).Alternatively, piezo motor (210) may be used for other purposes, or mayme simply omitted altogether. Encoder (220) may be configured to gatherand transmit information indicative of the rotational and/ortranslational position of cutter (54). In addition or in thealternative, encoder (220) may be configured to gather and transmitinformation indicative of the rotational position of a portion of tissuesample holder (140) (e.g., indicative of how many tissue sample chambersin tissue sample holder have been indexed to cutter lumen (56), etc.).Alternatively, encoder (220) may be used to gather any other type ofinformation, or may be simply omitted altogether. To the extent that anencoder (220) is used, encoder (220) may be provided in any suitablelocation, such as holster (200), probe (300), somewhere between biopsydevice (250) and control module interface (100), within control moduleinterface (100), or any other suitable location (e.g., to minimize MRinterference or for other purposes).

Other suitable features of or for holster (200) are disclosed in U.S.Non-Provisional patent application Ser. No. 12/337,997, entitled “TISSUEBIOPSY DEVICE WITH CENTRAL THUMBWHEEL,” filed on even date herewith, thedisclosure of which is incorporated by reference herein. Still othersuitable features of or for holster (200) are disclosed in U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. Alternatively, holster (200) may haveany other suitable structures, features, components, and configurations,as desired. Similarly, holster (200) may be operated in accordance withany of the teachings of U.S. Non-Provisional patent application Ser. No.12/337,997, entitled “TISSUE BIOPSY DEVICE WITH CENTRAL THUMBWHEEL,”filed on even date herewith, the disclosure of which is incorporated byreference herein; and/or U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein.

II. Exemplary Input Device

As shown in FIG. 1, input device (900) is in direct communication withcontrol module interface (100) via a data communication link (102).Input device (900) is also indirectly in communication with holster(200) and vacuum control module (400) via control module interface(100). Input device (900) may comprise a keypad, touch screen, keyboard,foot switch, or any other suitable device. Input device (900) may beconfigured to receive input (e.g., commands and signals, etc.) from auser in order to allow a user to operate one or more components ofbiopsy system (2), including holster (200) and/or vacuum control module(400). Input received via input device (900) may then be communicated tothe appropriate component via a data communications link (102). Datacommunication links (102) may comprise a communication cable, anelectrical cable, a wireless communication link, or any other suitablemethod or device. Input device (900) may be used in conjunction with oras an alternative to user interface (700) on vacuum control module (400)and/or in conjunction with or as an alternative to any user interfacethat may be presented by biopsy device (250). The connections andcommunication between input device (900) and control module interface(100) will be discussed in more detail below.

III. Exemplary Vacuum Control Module

As shown in FIG. 4, the vacuum control module (400) of the presentexample comprises an outer casing (414) and a user interface (700). Insome versions, vacuum control module (400) may further comprise a set ofoperational electronics (not shown) as an alternative to or in additionto the set of operational electronics housed within control moduleinterface (100). The operational electronics may be configured tocontrol one or more components of biopsy device system (2). Of course,operational electronics in vacuum control module (400) are not required.Outer casing (414) includes a face portion (420), behind which resides adisplay screen (702), capacitive switches (704), and a speaker (706).Face portion (420) is configured such that display screen (702) can beviewed therethrough; such that capacitive switches (704) may beactivated therethrough; and such that sounds coming from speaker (706)can be heard therethrough. Display screen (702), switches (704), andspeaker (706) may be regarded as collectively forming user interface(700). Vacuum control module (400) may be tilted to permit easierviewing of screen (702). Alternatively, a screen (702) may be externalto vacuum control module (400) permitting an operator to adjust theexternal screen to an appropriate position to facilitate viewing of andinteraction with the screen (702). Similar to input device (900), userinterface (700) may be configured to receive input (e.g., commands,signals, etc.) from a user, thereby allowing a user to control one ormore components of biopsy device system (2). Input from a user may becommunicated from vacuum control module (400) to control moduleinterface (100) or holster (200) via a data communication link (102).User interface (700) may be used in conjunction with or as analternative to external input device (900).

In the illustrated version, vacuum control module (400) also comprises afront connector (436) and a rear connector (438). Of course, anysuitable number of connectors (436, 438) in any suitable configurationmay be used. By way of example only, multiple connectors may be used tocommunicate power, electrical signals, etc. to or from vacuum controlmodule (400). It will be appreciated by those of ordinary skill in theart in view of the teachings herein that front connector (436) and/orrear connector (438) may be used to couple vacuum control module (400)with a variety of other devices, including but not limited to aninterface, such as control module interface (100), a local or remotedesktop or laptop computer, the internet, a local area network, anyother network, a storage device, or a device associated with one or moreparticular imaging modalities (e.g., a pod or cart associated withMagnetic Resonance Imaging, etc.).

Front connector (436) and rear connector (438) may permit data and/orcommands to be communicated between vacuum control module (400) and anexternal device, such as control module interface (100), holster (200)and input device (900). By way of example only, front connector (436)may provide power to either or both motors (150, 210). Alternatively,front connector (436) may provide power (e.g., phased power) to motor(150); while rear connector (438) provides power to piezo motor (210)(e.g., through piezo controller (130), etc.). Of course, those roles ofconnectors (436, 438) could be reversed, as desired. Cutter positionfeedback from encoder (220) may also be communicated back to vacuumcontrol module (400) via front connector (436) or rear connector (438).Similarly, to the extent that another encoder (not shown) is provided toobtain information on the rotational position of a rotational componentof tissue sample holder (140), such position feedback may becommunicated back to vacuum control module (400) via front connector(436) or rear connector (438). Other ways in which front connector (436)and rear connector (438) may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

Vacuum control module (400) may be configured and/or operated inaccordance with any of the teachings of U.S. Pub. No. 2008/0195066,entitled “Revolving Tissue Sample Holder For Biopsy Device,” publishedAug. 14, 2008, the disclosure of which is incorporated by referenceherein.

IV. Exemplary Control Module Interface

As illustrated by FIG. 1, control module interface (100) is configuredto serve as an electrical and mechanical interface between holster(200), input device (900), and vacuum control module (400). As notedabove, in certain environments, it may be beneficial to containmagnetically sensitive components, including but not limited to electricmotors and operational electronics, such as controllers, in a separateunit, such as control module interface (100). This modularization mayallow a user to remotely position these components to avoid interferencewith other pieces of equipment. As shown in FIGS. 5-6, control moduleinterface (100) of the present example comprises a cabinet (110), amicrocontroller circuit board (120), a piezo motor controller (130), anelectrical connector (140), a motor (150), and a shaft connectionassembly (160).

In the present example, control module interface (100) is provided as asimple retrofit to a preexisting vacuum control module (400). Forinstance, a user may already have a vacuum control module (400) that isconstructed in accordance with the teachings of U.S. Pub. No.2008/0195066, entitled “Revolving Tissue Sample Holder For BiopsyDevice,” published Aug. 14, 2008, the disclosure of which isincorporated by reference herein. The user may easily couple controlmodule interface (100) with vacuum control module (400), and controlmodule interface (100) may cooperate with vacuum control module (400)with relative ease. For instance, control module interface (100) may becoupled with front connector (436) of vacuum control module (400), andvacuum control module (400) may be operable in the same way it would behaving a biopsy device coupled directly to front connector (436) (e.g.,without a control module interface (100) being positioned between thebiopsy device and the vacuum control module (400). Alternatively, thepresence of control module interface (100) may provide additionalfunctionalities to vacuum control module (400) and/or disable certainfunctionalities of vacuum control module (400). If desired, various waysin which vacuum control module (400) may become aware of the coupling ofcontrol module interface (100) will be apparent to those of ordinaryskill in the art in view of the teachings herein. Alternatively, vacuumcontrol module (400) may be kept oblivious to the coupling of controlmodule interface (100). Vacuum control module (400) may attach to thetop of control module interface (100) (or vice-versa); within controlmodule interface (100) (or vice-versa); or elsewhere. Vacuum controlmodule (400) and/or control module interface (100) may also be mobile(e.g., of a size and weight such that a single person may carry eitheror both with relative ease).

A. Exemplary Cabinet

In the illustrated version, cabinet (110) comprises a lower body (111),a removable lid (112), a plurality of mounting extensions (114), anelectrical connector opening (116), a shaft connection assembly opening(117) and a rear opening (118). Removable lid (112) is releasablyengaged with lower body (111). Removable lid (112) may be attached tolower body (111) using one or more suitable fasteners, including but notlimited to screws, pins, bolts, hinges, etc. As shown in FIGS. 3-5,cabinet (110) includes four mounting extensions (114) positioned on eachof the four corners of lower body (111). Mounting extensions (114) maybe configured to allow cabinet (110) to be mounted to cart (50), asshown in FIG. 2, or any other suitable structure. Of course, mountingextensions (114) may alternatively be varied in any suitable way, asdesired, if not omitted altogether.

In this embodiment, electrical connector opening (116) and shaftconnection assembly opening (117) are positioned along a front-facingportion of lower body (111). In addition, electrical connector opening(116) is configured to accommodate electrical connector (140), whileshaft connection assembly opening (117) is configured to accommodateshaft connection plug (162) of shaft connection assembly (160). Rearopening (118) is positioned along a rear-facing portion of lower body(111) and is configured to provide access to the interior cavity ofcabinet (110) for additional wiring, cables, or other connection orpower components. Other suitable configurations and positions forelectrical connector opening (116), shaft connection assembly opening(117) and rear opening (118) will be apparent to those of ordinary skillin the art in view of the teachings herein.

As shown in FIGS. 6-7, cabinet (110) comprises a plurality ofcompartments (121, 131, 151, 161) configured to individually housevarious components, including microcontroller circuit board (120), piezomotor controller (130), electrical connector (140), motor (150), andshaft connection assembly (160). In the illustrated version, compartment(121) houses microcontroller circuit board (120) and includes slits inthe bottom face of lower body (111) to provide ventilation. Compartment(131) is configured to house piezo motor controller (130). Mountingplate (132) is configured to fit within compartment (131) and securepiezo motor controller (130). As shown, motor (150) is housed withincompartment (151), while compartment (161) is adjacent to shaftconnection assembly opening (117) and houses shaft connection assembly(160). Motor mounting plate (154) is configured to secure motor (150)within compartment (151). Of course, cabinet (110) may be configured tohouse any suitable number of components in any suitable configuration.Components, such as microcontroller circuit board (120) and piezo motorcontroller (130) may be secured to lower body (111) using screws, bolts,pins, adhesive, mounting plates, or any other suitable structures ortechniques.

Lower body (111) may also include channels formed within lower body(111), such as channels (113, 115), configured to allow the componentsto be connected. For example, channel (113) provides a pathway for aconnection between piezo motor controller (130) and electrical connector(140). Similarly, channel (115) provides a pathway for a connectionbetween microcontroller circuit board (120) and motor (150). Anysuitable number of channels in any suitable configuration may beincorporated within lower body (111).

B. Exemplary Operational Electronics

Control module interface (100) of the present example comprisesoperational electronics, including microcontroller circuit board (120)and piezo motor controller (130) operable to control various componentsof biopsy system (2). The operational electronics contained in controlmodule interface (100) may be incorporated in biopsy device system (2)as an alternative to or in addition to operational electronics housedwithin vacuum control module (400) or elsewhere. Microcontroller circuitboard (120) and piezo motor controller (130) may be configured tocontrol and/or receive input from one or more external devices connectedto control module interface (100), including but not limited to holster(200), input device (900), and vacuum control module (400). Inparticular, among other operations, microcontroller circuit board (120)is operable to control motor (150) housed within cabinet (110) and piezomotor controller (130) is operable to control piezo motor (210) housedwithin holster (200).

As discussed above, a user may input commands or signals to operate oneor more components of biopsy system (2) via input device (900) or userinterface (700). In this example, such input is communicated to controlmodule interface (100) via a data communication link (102), and, moreparticularly, microcontroller circuit board (120) or piezo motorcontroller (130). That input may be processed by microcontroller circuitboard (120) and/or piezo motor controller (130), along with other inputfrom various signals and sensors (not shown), to control motor (150)and/or piezo motor (210) in accordance with the user's instructions.

By way of example only, microcontroller circuit board (120) and/or piezomotor controller (130) may be configured in accordance with any of therelevant teachings of U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder For Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein. Alternatively,any other suitable configurations may be used.

C. Exemplary Motors

In the illustrated version, motor (150) is configured to drive cutterdriver mechanism (230) incorporated within holster (202). Alternatively,motor (150) may be configured to drive additional or alternativecomponents within holster (202). As shown, motor (150) comprises arotatable output shaft (152). Output shaft (152) is remotely connectedto cutter drive mechanism (230) via shaft connection assembly (160) andmechanical cable (215), as noted above. By way of example only, as alsonoted above, mechanical cable (215) may comprise a flexible shaft cable,such as a speedometer cable. Of course, other suitable cables, as wellas other suitable devices or techniques to communicate rotation frommotor (150) to cutter drive mechanism (230) will be apparent to those ofordinary skill in the art based on the teachings herein. The connectionbetween motor (150) and cutter drive mechanism (230) will be discussedin greater detail below. Motor (150) may incorporate brushed orbrushless technology. Motor (150) may also use electrical or opticalcommutation, although this is not required. For instance, motor (150)may comprise a 24 VDC motor (e.g., 60 W brush motor, EC22 50 W BLDCmotor, a 60 W BDC motor, 8 W BLDC motor, etc.), or any other suitabletype of motor. Motor (150) may also be coupled with an encoder (notshown) within control module interface (100), such as to gatherinformation on rotational positioning and/or speed of motor (150), etc.

D. Exemplary Communication Between Components

In the present example, control module interface (100) is configured tohouse certain mechanical and electrical components such that controlmodule interface (100) may be positioned remotely from one or morecomponents of biopsy system (2) (e.g., remotely from biopsy device(250). The remote positioning is possible because control moduleinterface (100) is configured to remain in electrical and/or mechanicalcommunication with each of the other components of biopsy system (2). Asillustrated in FIG. 1, control module interface is in mechanical andelectrical communication with holster (200), input device (900), andvacuum control module (400).

In the present example, data communication links (102) are configured toallow data, including but not limited to commands, control signals,sensor signals, etc., to be communicated between control moduleinterface (100) and the other components of biopsy device system (2).Data communication links (102) may comprise a communication cable, anelectrical cable, a wireless communication link, or any other suitablestructure or means of communication. In embodiments where datacommunication links (102) comprise a physical cable (such as acommunication or electrical cable), data communication links (102) maybe of sufficient length to allow the user to place control moduleinterface (100) sufficiently far away from any magnetic resonanceimaging equipment to avoid interference resulting from any magneticfield (e.g., at 1 Tesla, etc.) created by the MR imaging equipment. Forinstance, a suitable distance may be in the range of between about 10feet and about 12 feet, or any other suitable distance. Physical cablesfor data and/or electrical communication may or may not also be coupledwith mechanical cable assembly (e.g., secured external to or internal tosheath (219), etc.).

Data communication links (102) may be connected to control moduleinterface (100) and its components via electrical connector (140).Control module interface (100) serves as an intermediate processor forcommunication between holster (200), input device (900), and vacuumcontrol module (400). For example, in the illustrated embodiment, if auser attempts to operate holster (200) by entering in a command via userinterface (700) on vacuum control module (400), the command iscommunicated from interface (700) to control module interface (100) viaa data communication link (102), processed by microcontroller circuitboard (120) and/or piezo motor controller (130), and, subsequentlycommunicated to holster (200) via a data communication link (102).Similarly, a command entered into input device (900) is communicatedfrom input device (900) to control module interface (100) via a datacommunication link (102), processed by microcontroller circuit board(120) or piezo motor control (130) and, subsequently communicated toholster (200) or vacuum control module (400) as appropriate via a datacommunication link (102). In addition, feedback, such as signalsgenerated by encoder (220), may also be communicated to control moduleinterface (100) via a data communication link (102), processed, and,ultimately, communicated to vacuum control module (400) via a datacommunication link (102) to generate a display on user interface (700)or for some other operational use.

Control module interface (100) may further comprise an internal datacommunication link (103) configured to allow communication betweenmicrocontroller circuit board (120), piezo motor controller (130), andmotor (150). In particular, commands to operate motor (150) may beprocessed by microcontroller circuit board (120) and subsequentlycommunicated to motor (150) via communication link (103). Such commandsmay be influenced at least in part by cutter position data communicatedby encoder (220). Piezo motor controller (130) may or may not be incommunication with each other, as desired.

An extra encoder (not shown) may be included in holster (200), forsensing the rotational position of a rotatable component of tissuesample holder (140). Data from such an encoder may be communicated backto circuit board (120) and/or piezo motor controller (130), to at leastpartially influence operation of motor (210). By way of example only,piezo motor controller (130) may drive motor (210) by transmitting abi-phase sinusoidal waveform, with phase being locked to the rotationalfrequency. Of course, any other suitable type of waveform or other typeof control signal may be used. It should also be understood that anyother suitable type of motor controller may be used, in addition to orin lieu of a piezo motor controller (130). The inventors thuscontemplate a variety of types of motors and motor controllers as beingusable, in addition to or in lieu of a piezo motor (210) and a piezomotor controller (130).

Control module interface (100) may also be configured to receive powerfrom an external device. In the illustrated version, power communicationlinks (104) communicate power from vacuum control module (400) tocontrol module interface (100). Power communication links (104) may beconnected to control module interface (100) via electrical connector(140), through rear opening (118), or through any other suitableconnection. In particular, power to operate motor (150) is communicateddirectly from vacuum control module (400). In the present example, powerto operate piezo motor (210) is communicated from vacuum control module(400) through piezo motor controller (130) and, ultimately, to piezomotor (210) via an additional power communication link (not shown)between control module interface (100) and piezo motor (210).Alternatively, power may be communicated to piezo motor (210) viacommunication link (102) between control module interface (100) andpiezo motor (210).

In the present example, control module interface (100) is also inmechanical communication with holster (200). More precisely, motor (150)is mechanically connected to cutter drive mechanism (230) in holster(200) via a mechanical cable (215). As shown, and as described above,mechanical cable (215) is configured to translate rotational motiongenerated by motor (150) to cutter drive mechanism (230). Mechanicalcable (215) may comprise a flexible shaft cable, such as a speedometercable, or any other suitable device or technique. Mechanical cable (215)may be of sufficient length to allow the user to place control moduleinterface (100) sufficiently far away from any magnetic resonanceimaging equipment to avoid interference resulting from any magneticfields created by the imaging equipment. Motor (150) is configured torotate output shaft (152). Output shaft is connected to mechanical cable(215) via shaft connection assembly (160).

As shown in FIGS. 8-10, shaft connection assembly (160) comprises aflexible coupling (162), shaft connector (164), shaft plug (166), andshaft locking nut (168). Flexible coupling (162) is configured to engageoutput shaft (152) and shaft connector (164) such that output shaft(152) and shaft connector (164) rotate unitarily. Shaft connector (164)comprises an opening (165) configured to receive an end of mechanicalcable (215) (in particular, the end of flexible cable (217)). In theillustrated version, opening (165) is star-shaped, however othersuitable shapes or configurations will be apparent to those of ordinaryskill in the art based on the teachings herein. One end of mechanicalcable (215) is inserted into shaft connector (164) such that mechanicalcable (215), output shaft (152), and shaft connector (164) rotateunitarily. Once mechanical cable (215) is inserted into shaft connector(164) and connected to cutter driver mechanism (230) at the oppositeend, mechanical cable (215) is capable of communicating rotationgenerated by motor (150) to cutter driver mechanism (230). Shaft plug(166) is configured to occupy shaft connection assembly opening (117),and shaft locking nut (168) is configured to secure shaft plug (166)within shaft connection assembly opening (117).

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A biopsy system comprising: a. a first external device; b. a biopsydevice comprising a housing and an internal motor, wherein the internalmotor is disposed within the housing; and c. a control module interfacein electrical communication with both the first external device and thebiopsy device, wherein the control module interface is in mechanicalcommunication with the biopsy device and disposed exterior to thehousing of the biopsy device, wherein the control module interface isconfigured to be positioned remotely from at least one of the firstexternal device or the biopsy device, wherein the control moduleinterface comprises i. a motor comprising an output shaft, wherein themotor of the control module interface is in mechanical communicationwith the biopsy device via a mechanical cable, ii. operationalelectronics configured to permit control of the motor of the controlmodule interface and the internal motor of the biopsy device, iii. ashaft connection assembly configured to engage the output shaft and themechanical cable, wherein the shaft connection assembly is configured tofacilitate communication of rotational motion generated by the motor ofthe control module interface to the biopsy device via the mechanicalcable, iv. an electrical connector configured to communicate power andelectrical signals between the first external device and the controlmodule interface, wherein the electrical connector is further configuredto communicate power and electrical signals between the control moduleinterface and the biopsy device, and v. a cabinet configured to housethe motor of the control module interface and the operationalelectronics.
 2. The biopsy system of claim 1, wherein the first externaldevice comprises a vacuum control module having a user interfacecomprising an input device configured to allow a user to input commandsto operate at least one of the control module interface or the biopsydevice.
 3. The biopsy system of claim 1, wherein the biopsy devicecomprises a probe assembly and a holster assembly, wherein the internalmotor is located within the holster assembly.
 4. The biopsy system ofclaim 3, wherein the holster assembly comprises a cutter drivemechanism, wherein the mechanical cable is engaged with the cutter drivemechanism such that rotational motion generated by the motor of thecontrol module interface is communicated to the cutter drive mechanismvia the mechanical cable.
 5. The biopsy system of claim 3, wherein theinternal motor of the biopsy device comprises a piezo motor.
 6. Thebiopsy system of claim 5, wherein the operational electronics comprise apiezo motor controller configured to control the piezo motor.
 7. Thebiopsy system of claim 6, wherein the operational electronics furthercomprise a microcontroller circuit board, wherein the microcontrollercircuit board is configured to control the motor of the control moduleinterface.
 8. The biopsy system of claim 1, wherein the operationalelectronics comprise a microcontroller circuit board, wherein themicrocontroller circuit board is configured to control the motor of thecontrol module interface.
 9. The biopsy system of claim 1, wherein themechanical cable comprises a flexible shaft cable.
 10. The biopsy systemof claim 1, wherein the control module interface is configured toreceive power from the first external device, wherein the first externaldevice is configured to provide power to the motor housed in the controlmodule interface.
 11. The biopsy system of claim 1, wherein the shaftconnection assembly comprises: a. a shaft connector configured to engagethe mechanical cable, wherein the shaft connector and the mechanicalcable are configured to rotate unitarily; and b. a flexible couplingcomprising a first end and a second end, wherein the flexible couplingis configured to engage the shaft connector at the first end and engagethe output shaft at the second end, wherein the flexible coupling causesthe output shaft and the shaft connector to rotate unitarily.
 12. Thebiopsy system of claim 1, further comprising a cart, wherein at leastone of the first external device and the control module interface arecoupled with the cart.
 13. The biopsy system of claim 1, furthercomprising a third external device, wherein the control module interfaceis configured to serve as an interface between the first externaldevice, the biopsy device, and the third external device, wherein thecontrol module interface is configured to be positioned remotely from atleast one of the first external device, the biopsy device, or the thirdexternal device, wherein the third external device comprises an inputdevice configured to allow a user to input commands to operate at leastone of the first external device or the biopsy device.
 14. The biopsysystem of claim 13, wherein the third external device is selected fromthe group consisting of a keypad, a keyboard, and a touch-screen. 15.The biopsy system of claim 1, wherein the biopsy device comprises acutter in communication with the motor of the control module interface,and wherein the rotational motion generated by the motor of the controlmodule interface is convertible into a simultaneous rotation andtranslation of the cutter.
 16. The biopsy system of claim 1, wherein thecontrol module interface is configured to be positioned remotely fromthe biopsy device such that the shaft connection assembly of the controlmodule interface is positioned remotely from the biopsy device, andwherein the shaft connection assembly is disposed between the outputshaft and the mechanical cable.
 17. The biopsy system of claim 1,wherein the biopsy device and the first external device are disposedexterior to the cabinet of the control module interface.
 18. A biopsysystem comprising: a. a biopsy device comprising i. a housing, ii. acutter, iii. an internal motor, and iv. a tissue sample holder, whereinthe internal motor is disposed within the housing, and wherein theinternal motor is operable to drive the tissue sample holder; and b. acontrol module in mechanical communication with the biopsy device anddisposed exterior to the housing of the biopsy device, wherein thecontrol module is configured to be positioned remotely from the biopsydevice, wherein the control module comprises i. a motor comprising anoutput shaft, wherein the motor of the control module is in mechanicalcommunication with the biopsy device via a mechanical cable, and whereinthe motor of the control module is operable to drive the cutter of thebiopsy device, ii. operational electronics configured to permit controlof the motor of the control module, iii. a shaft connection assemblyconfigured to engage the output shaft and the mechanical cable, whereinthe shaft connection assembly is configured to facilitate communicationof rotational motion generated by the motor of the control module to thebiopsy device via the mechanical cable.
 19. The biopsy system of claim18, wherein the internal motor of the biopsy device comprises a piezomotor, and wherein the operational electronics comprise a piezo motorcontroller configured to control the piezo motor.
 20. A biopsy systemcomprising: a. a biopsy device comprising i. a housing, ii. a cutter,iii. an internal motor, and iv. a tissue sample holder, wherein thetissue sample holder defines a longitudinal axis, a distal end of thecutter is disposed at a distal end of the biopsy device, wherein thetissue sample holder is disposed at an opposite, proximal end of thebiopsy device, wherein the internal motor is disposed within thehousing, and wherein the internal motor is operable to drive the tissuesample holder in a rotational motion about the longitudinal axis; and b.a control module in mechanical communication with the biopsy device anddisposed exterior to the housing of the biopsy device, wherein thecontrol module is configured to be positioned remotely from the biopsydevice, wherein the control module comprises i. a motor comprising anoutput shaft, wherein the motor of the control module is in mechanicalcommunication with the biopsy device via a mechanical cable, and whereinthe motor of the control module is operable to drive the cutter of thebiopsy device, and ii. operational electronics configured to permitcontrol of the motor of the control module and the internal motor of thebiopsy device.